FDA Inspection 735952 — J & M Cylinder Gases Inc
The FDA completed an inspection of J & M Cylinder Gases Inc on Jul 8, 2011 in Decatur, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 8, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Decatur, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1506 | 21 CFR 211.122(e) | Destruction of obsolete labeling |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |